PharMEDium Recalls Fentanyl Citrate IV Bags Due to CGMP Deviations
PharMEDium Services is recalling specific lots of Fentanyl Citrate IV bags because they were released while a hood certification discrepancy was under investigation.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or deaths, and the hazard is a procedural CGMP deviation rather than a confirmed contamination or defect causing harm.
Plain-English summary
PharMEDium Services, LLC is recalling 230 Intravia Bags of 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride. The affected products include 250 mL bags in 250 mL Intravia Bags and 100 mL bags in 150 mL Intravia Bags. The specific lots involved are 181760013D and 181730007D, with expiration dates of 08/09/2018 and 09/02/2018.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was released while a hood certification discrepancy was being investigated. The agency has classified this recall as Class II.
The product was distributed throughout the United States. Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If found, the product should be quarantined and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — IV Infusion
- Affected units
- 230
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot 181760013D
- 181730007D
- Exp 08/09/2018
- 09/02/2018
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by PharMEDium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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